A mixed methodology, non-interventional study to evaluate the use of direct oral anticoagulants in UK clinical practice for patients with a first stroke associated with non-valvular atrial fibrillation: study protocol.

BACKGROUND: Treatment with anticoagulants, including direct oral anticoagulants (DOACs), should be considered for patients diagnosed with atrial fibrillation (AF) deemed at risk of ischaemic stroke. There are limited real world data related to the characteristics of patients with non-valvular AF who were not taking anticoagulants at the time of first ischaemic stroke and their subsequent DOAC treatment for the secondary prevention of stroke. Furthermore, little is known about patient adherence and experiences of DOAC treatment, especially for patients with non-valvular AF receiving DOAC therapy for the secondary prevention of stroke. METHODS: This is a UK mixed methodology, non-interventional study, involving retrospective and prospective medical record reviews and a prospective patient survey, in progress in six UK National Health Service secondary/tertiary care centres. The study comprises two groups of patients. Group 1 will include 300 eligible consenting patients with a first ischaemic stroke associated with non-valvular AF untreated with anticoagulants in the 12 months prior to stroke. Group 2 will include a subgroup of 150 patients from Group 1 initiated on one of the DOACs targeting activated Factor X (n = 50 on apixaban, n = 50 on edoxaban and n = 50 on rivaroxaban). The primary endpoint of the study is the CHA2DS2-VASc Risk Score prior to initiation of anticoagulation for patients included in Group 1. Secondary endpoints to be evaluated in Group 1 include patient demographics, clinical characteristics, relevant medical history, anticoagulant therapy initiated for secondary prevention of stroke, and relevant concomitant medication. Secondary endpoints to be evaluated in Group 2 include the time between stroke and DOAC initiation; prescribing of DOACs, other anticoagulants and concomitant medication; clinical assessments and hospital resource use; patient reported outcome measures, including the Morisky Medication Adherence Scale questionnaire and the Treatment Satisfaction Questionnaire for Medication. DISCUSSION: This mixed methodology study will provide new real world insights into the characteristics and management pathways and patient-reported experiences of this important group of patients. It is anticipated that the results of this study will provide the medical community and patients with important information to inform clinical decision-making and help facilitate meaningful improvements in the care of patients with non-valvular AF.

A study of the healthcare resource use for the management of postpartum haemorrhage in France, Italy, the Netherlands, and the UK.

OBJECTIVE: Postpartum haemorrhage (PPH) complicates approximately 5% of births worldwide and is a leading direct cause of maternal death. Rates of PPH are increasing in many developed countries, particularly PPH related to uterine atony. There is a lack of published up-to-date information about healthcare resource use associated with management of PPH following vaginal birth. The objective of this study was to describe healthcare resource use for the management of minor PPH (blood loss 500-1,000 ml) and major PPH (blood loss > 1,000 ml) compared to uncomplicated birth (no PPH) following hospital vaginal birth in France, Italy, the Netherlands, and the UK. STUDY DESIGN: In-depth interviews with two midwives from each participating country were conducted to establish differences in resource use for the management of minor PPH, major PPH, and uncomplicated birth. A web-survey was then developed and one obstetrician per participating country reviewed the survey. In total, 100 midwives (25 per country) completed the survey. Results were discussed at a multi-professional consensus meeting of midwives and obstetricians/gynaecologists (n = 6). RESULTS AND CONCLUSIONS: Midwives participating in the survey estimated that 80% of women receive Active Management of the Third Stage of Labour (AMTSL) and 93% of participants specified that uterotonics would routinely be used during AMTSL. Most participants (84%) reported that blood loss is routinely measured in their hospital, using a combination of methods. PPH is associated with increased healthcare resource use, including administration of additional uterotonics and use of additional medical interventions, such as urinary catheter, intravenous fluids, and possible requirement for surgery. The number of nurses, obstetricians/gynaecologists, and anaesthetists involved in the management of PPH increases with the occurrence and severity of PPH, as well as the proportion of healthcare personnel providing continuous care. Women may spend an additional 24 h in hospital following major PPH compared to uncomplicated birth. The results of this study highlight the burden of PPH management on healthcare resources. To reduce costs associated with PPH, prevention is the most effective strategy and can be enhanced with the use of an effective uterotonic as part of the active management of the third stage of labour.

COVID-19-associated hospitalizations among children less than 12 years of age in the United States.

OBJECTIVES: To describe the characteristics, healthcare resource use and costs associated with initial hospitalization and readmissions among pediatric patients with COVID-19 in the US. METHODS: Hospitalized pediatric patients, 0-11 years of age, with a primary or secondary discharge diagnosis code for COVID-19 (ICD-10 code U07.1) were selected from 1 April 2020 to 30 September 2021 in the US Premier Healthcare Database Special Release (PHD SR). Patient characteristics, hospital length of stay (LOS), in-hospital mortality, hospital costs, hospital charges, and COVID-19-associated readmission outcomes were evaluated and stratified by age groups (0-4, 5-11), four COVID-19 disease progression states based on intensive care unit (ICU) and invasive mechanical ventilation (IMV) usage, and three sequential calendar periods. Sensitivity analyses were performed using the US HealthVerity claims database and restricting the analyses to the primary discharge code. RESULTS: Among 4,573 hospitalized pediatric patients aged 0-11 years, 68.0% were 0-4 years and 32.0% were 5-11 years, with a mean (median) age of 3.2 (1) years; 56.0% were male, and 67.2% were covered by Medicaid. Among the overall study population, 25.7% had immunocompromised condition(s), 23.1% were admitted to the ICU and 7.3% received IMV. The mean (median) hospital LOS was 4.3 (2) days, hospital costs and charges were $14,760 ($6,164) and $58,418 ($21,622), respectively; in-hospital mortality was 0.5%. LOS, costs, charges, and in-hospital mortality increased with ICU admission and/or IMV usage. In total, 2.1% had a COVID-19-associated readmission. Study outcomes appeared relatively more frequent and/or higher among those 5-11 than those 0-4. Results using the HealthVerity data source were generally consistent with main analyses. LIMITATIONS: This retrospective administrative database analysis relied on coding accuracy and inpatient admissions with validated hospital costs. CONCLUSIONS: These findings underscore that children aged 0-11 years can experience severe COVID-19 illness requiring hospitalization and substantial hospital resource use, further supporting recommendations for COVID-19 vaccination.

Economic Burden of Treatment-Resistant Depression Among Patients Hospitalized for Major Depressive Disorder in the United States.

Objectives: This study aimed to evaluate hospital length of stay (LOS) and cost as well as readmission risk and the associated economic burden among patients hospitalized for treatment-resistant and non-treatment-resistant major depressive disorder. Methods: Adult patients with a primary hospital discharge diagnosis of major depressive disorder were identified from the Premier Hospital Database (January 1, 2012-September 30, 2015). Patients were stratified into two cohorts: those whose hospital treatment was suggestive of treatment-resistant depression and those with non-treatment-resistant depression. Hospital LOS and cost during the initial admission and readmissions rates, LOS, and cost within the 6-month follow-up were compared between cohorts with a propensity score-matched sample. Results: After matching, 45,066 patients were included in each cohort. For index hospitalizations, mean hospital LOS was longer (7.4 vs. 5.9 days, p<0.001) and mean hospital cost higher ($8,681 vs. $6,632, p<0.001) for patients with treatment-resistant depression vs. non-treatment-resistant depression. Rates for all-cause (24.4% vs. 20.0%, p<0.001), major depressive disorder-related (17.0% vs. 13.3%, p<0.001), and suicidal ideation/suicide attempt-related (12.8% vs. 9.5%, p<0.001) readmissions were higher for patients with treatment-resistant depression. Mean LOS and total hospital costs per patient for readmissions were also greater for patients with treatment-resistant depression vs. non-treatment-resistant depression. Correspondingly, the combined hospital cost (index hospitalization+all-cause readmissions) was greater for patients with treatment-resistant depression ($12,370 vs. $9,429, p<0.001). Conclusions: Treatment-resistant depression was associated with substantial economic burden among patients hospitalized for major depressive disorder. More-effective treatment and care for this patient population may reduce the hospital burden of patients with treatment-resistant depression.

Impact of Powered and Tissue-Specific Endoscopic Stapling Technology on Clinical and Economic Outcomes of Video-Assisted Thoracic Surgery Lobectomy Procedures: A Retrospective, Observational Study.

INTRODUCTION: Video-assisted thoracic surgery (VATS) lung resections are complex procedures with a critical role played by endoscopic staplers in the transection of vessels, bronchi, and lung tissue. This retrospective, observational study compared hospital resource use, costs, and complications of VATS lobectomy procedures for whom powered versus manual endoscopic surgical staplers were used. METHODS: Patients ≥ 18 years of age undergoing elective VATS lobectomy during an inpatient admission from January 1, 2012 to September 30, 2016 were identified from the Premier Healthcare Database (first admission = index admission). Use of either powered or manual endoscopic staplers during the index admission was identified from hospital administrative records. Multivariable regression analyses adjusting for patient, hospital, and provider characteristics and hospital-level clustering were carried out to compare the following outcomes between the powered and manual stapler groups: hospital length of stay (LOS), operating room time (ORT), hospital costs, complications (bleeding and/or transfusions, air leak complications, pneumonia, and infection), discharge status, and 30-, 60-, and 90-day all-cause readmissions. RESULTS: The powered and manual stapler groups comprised 659 patients (mean age 66.1 years; 53.6% female) and 3100 patients (mean age 66.7 years; 54.8% female), respectively. In the multivariable analyses, the powered stapler group had shorter LOS (4.9 vs. 5.9 days, P < 0.001), lower total hospital costs ($23,841 vs. $26,052, P = 0.009), and lower rates of combined hemostasis complications (bleeding and/or transfusions; 8.5% vs. 16.0%, P < 0.001) and transfusions (5.4% vs. 10.9%, P = 0.002), compared with the manual stapler group. Other outcomes did not differ significantly between the study groups. Similar trends were observed in subanalyses comparing devices across predominant manufacturers in each group, and in subanalyses of patients with comorbid chronic obstructive pulmonary disease. CONCLUSION: In this analysis of VATS lobectomy procedures, powered staplers were associated with significant benefits with respect to selected types of hospital resource use, costs, and clinical outcomes when compared with manual staplers. FUNDING: Johnson & Johnson.

Quality of care and in-hospital resource use in acute myocardial infarction: evidence from Japan.

OBJECTIVES: To determine the association between quality of care in process and outcome measures and in-hospital resource use among patients admitted for acute myocardial infarction (AMI) in Japan. METHODS: We analyzed 23,512 AMI patients across 150 hospitals in Japan between April 2008 and March 2011. The exposure measure was inpatient hospital resource use, which was calculated from the sum of all hospital fees for healthcare services provided to AMI patients. Hospitals were then categorized into quartiles based on a risk-adjusted in-hospital resource use index. Quality of care was assessed using three process measures (in-hospital prescription of aspirin, ß-blockers, and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers) and two outcome measures (7-day and 30-day in-hospital mortality). Process and outcome measures were analyzed with multilevel logistic regression models that adjusted for patient and hospital characteristics. RESULTS: No significant differences in process measures were observed across the quartiles of in-hospital resource use. In contrast, hospitals with the lowest resource use were significantly associated with poorer outcomes (7-day in-hospital mortality OR: 1.851 [95% CI 1.327-2.582]; 30-day in-hospital mortality OR: 1.706 [95% CI 1.259-2.312]) than hospitals with higher resource use. CONCLUSION: Poorer quality of care in outcome measures was significantly associated with lower resource utilization among AMI patients in Japanese hospitals, but process measures did not show similar associations.